A Study of Daratumumab in Combination With Atezolizumab Compared With Atezolizumab Alone in Participants With Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer
The purpose of the study is to compare the overall response rate (ORR) in non-small cell lung cancer (NSCLC) participants treated with daratumumab in combination with atezolizumab versus atezolizumab alone.
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This describes the study’s primary purpose.
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These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Nov 20, 2019 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Janssen Research & Development, LLC
- Interventions being studied
- Drug: Atezolizumab; Drug: Daratumumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Have histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC) (Stage IIIb or greater)
- Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Tumor cell programmed death-ligand 1 (PD-L1) score of tumor cells (TC)1-3 and immune cell PD-L1 score of tumor-infiltrating immune cells (IC)0-3 as determined by an immunohistochemistry (IHC) assay performed by the central laboratory on tissue obtained after the last line of therapy
- A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta- hCG\]) at Screening within 14 days prior to study drug administration Inclusion Criteria for Crossover:
- Participants must have been randomized to Arm A of the study and had radiographic disease progression according to RECIST 1.1
- Participants must have a mandatory biopsy at the time of disease progression according to RECIST 1.1 prior to crossing over. If not clinically feasible, discussion with Sponsor is required
- The first dose of atezolizumab in the crossover arm should be within 42 days of last dose but no less than 21 days from the last dose prior to crossing over
- Received any of the following prescribed medications or therapies in the past: 1. Anti-cluster of differentiation(CD)38 therapy, including daratumumab 2. CD137 agonists, immune checkpoint inhibitors including but not limited to CTLA-4, anti-PD-1, and anti-PD-L1 therapies
- Known to be seropositive for human immunodeficiency virus (HIV)
- Prior allogeneic bone marrow transplantation or solid organ transplant
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- Active hepatitis B, defined by a positive test for hepatitis B surface antigen \[HBsAg\] or prior history of hepatitis B, defined by presence of antibodies to hepatitis B core antigen \[anti-HBc\], regardless of hepatitis B surface antibody \[anti-HBs\] status; active hepatitis C or prior history of hepatitis C (anti-HCV positive), except in the setting of a sustained virologic response (SVR), defined as aviremia 12 weeks after completion of antiviral therapy. If hepatitis C virus (HCV) antibodies are detected, an HCV RNA test for viral load by polymerase chain reaction (PCR) should be performed at least 12 weeks after completion of antiviral therapy to rule out active infection
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Study locationLoma Linda, California
- Study locationWhittier, California
- Study locationNewark, Delaware
- Study locationDeerfield Beach, Florida
- Study locationFort Lauderdale, Florida
- Study locationOrlando, Florida
- Study locationTampa, Florida
- Study locationAthens, Georgia
- Study locationAtlanta, Georgia
- Study locationNew Orleans, Louisiana
- Study locationBethesda, Maryland
- Study locationOklahoma City, Oklahoma
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 20, 2019. Always confirm current availability with the study team.